R3 71337652Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 03596010598493), received between Jan 8, 2018 and Mar 27, 2025 — classified as 11 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 reports).

3 other recalls cover devices cleared under the same FDA submission (K113848, K211176); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryMar 27, 2025Break; Fracture; Break; Fracture

  IT WAS REPORTED THAT, AFTER THR SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED A BREAKAGE OF AN R3 20 DEG XLPE ACET LNR 32MM X 52MM. THIS ADVERSE EVENT WAS ADDRESSED BY A REVISION SURGERY PERFORMED ON (B)(6) 2025 IN WHICH AN IMPLANT FROM A COMPETING MANUFACTURER WAS IMPLANTED. PATIENT'S HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant; Insufficient Information

  MAUDE report 21707802 ↗
• InjurySep 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, A RIGHT THR REVISION HAD TO BE CARRIED OUT ON (B)(6) 2023, DUE TO THE DISLOCATION OF A R3 20 DEG XLPE ACET LNR 32MM X 52MM AND OXINIUM FEM HD 12/14 32MM +8. BOTH IMPLANTS WERE EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN, FURTHER INFORMATION HAS NOT BEEN MADE AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 17785885 ↗
• InjuryMar 10, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, ON (B)(6) 2021, THE PATIENT UNDERWENT LEFT TOTAL HIP ARTHROPLASTY TO IMPROVE THE STRUCTURE OF THE PATIENT'S LEFT HIP, RELIEVE PAIN AND IMPROVE THE QUALITY OF LIFE. THE PROSTHESIS WAS NORMAL AND RECOVERED WELL AFTER OPERATION. ON (B)(6) 2022, THE PATIENT FELT AN ABNORMAL SOUND OF THE LEFT HIP JOINT, WHICH WAS OBVIOUS WHEN WALKING AND NEEDED TO WALK WITH A CRUTCH. ON (B)(6) 2022, A FILM IN THE OUTPATIENT DEPARTMENT OF THE HOSPITAL WAS TAKEN, WHICH SUGGESTED LOOSENING OF THE R3 20 DEG XLPE ACET LNR 32 MM X 52 MM. ON (B)(6) 2022, THE PATIENT UNDERWENT SURGICAL INCISION AND EXPLORATION, IT WAS FOUND THAT THE LINER WAS LOOSE AND THE LINER BUCKLE WAS WORN, AND ALSO THAT THE FEMORAL HEAD WAS WORN; THEREFORE, BOTH COMPONENTS WERE EXCHANGED. THE PATIENT IS CURRENTLY UNDERGOING POSTOPERATIVE REHABILITATION TREATMENT.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Failure of Implant; Inadequate Osseointegration

  MAUDE report 13720415 ↗
• InjuryDec 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2021, A R3 20 DEG XLPE ACET LNR 32 MM X 52 MM WAS IMPLANTED BY MISTAKE (DURING THE PROCEDURE IT WAS INCORRECTLY SELECTED). THIS ADVERSE EVENT WAS SOLVED BY BRINGING THE PATIENT BACK TO THE OPERATING ROOM FOR A THR REVISION SURGERY TO EXCHANGE THE R3 20 DEG XLPE ACET LNR 32 MM X 52 MM TO A 36 MM LINER. THERE WAS A DELAY OF GREATER THAN 30 MINUTES. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12969679 ↗
• MalfunctionDec 1, 2021Device Markings/Labelling Problem; No Apparent Adverse Event; Device Markings/Labelling Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT, DURING HIP REPLACEMENT, IT WAS THOUGHT THAT AN R3 ACETABULAR LINER 32MM INNER DIAMETER X OUTER DIAMETER 52MM HAD NUMBER 50 INSCRIBED ON THE EXTERNAL BOX OF THE IMPLANT, INSTEAD OF NUMBER 52. THE SURGERY WAS RESUMED, WITHOUT ANY DELAY, THE SAME DEVICE. WHEN REVIEWING THE IMPLANTS USED, IT WAS NOTICED THAT THE CAUSE WAS ASSOCIATED WITH AN OMISSION ON THE PART OF THE SURGICAL INSTRUMENTATION OPERATOR THAT CONFUSED THE MEASUREMENTS OF THE IMPLANT. PATIENT'S HEALTH IS STABLE AND WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12908661 ↗
• InjuryJan 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THA HAD BEEN PERFORMED ON (B)(6) 2020, THE PATIENT DISLOCATED THE PROSTHESIS FOR NOT CORRECTLY IMPACTING THE POLYETHYLENE. THE DEVICE HAS FAILED BECAUSE THE INSERT WAS NOT IMPACTED CORRECTLY AND IT WAS COMING OUT OF THE SHELL, RUBBING AGAINST THE FEMORAL HEAD. THE R3 20 DEG XLPE ACET LNR 32MM WAS REPLACED. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 11156128 ↗
• InjuryJan 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DUE TO A HIP DISLOCATION A REVISION SURGERY IS PERFORMED AT (B)(6) ON (B)(6) 2020.

  Patient problems: Failure of Implant; Joint Dislocation; No Clinical Signs, Symptoms or Conditions

  MAUDE report 11114304 ↗
• MalfunctionDec 3, 2020Positioning Failure; Incomplete or Inadequate Connection; Positioning Failure; Incomplete or Inadequate Connection

  IT WAS REPORTED DURING A PROCEDURE THE R3 20 DEG XLPE ACET LNR 32MM X 52MM DID NOT LOCK INTO R3 COATED SHELL DURING IMPACTION. THE ACETABULAR LINER WAS REPLACED WITH A NEW ONE. THE PROCEDURE HAD A DELAY BETWEEN 0-30 MIN. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10938578 ↗
• InjuryJan 17, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED SINCE PATIENT DISLOCATED 3 TIMES POST REVISION SURGERY.

  Patient problems: Injury

  MAUDE report 9601229 ↗
• InjuryMar 7, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE RECURRENT DISLOCATIONS. LINER WAS REMOVED. NO DELAY REPORTED AND NO BACKUP DEVICE WAS REQUIRED.

  Patient problems: Injury

  MAUDE report 8400242 ↗
• InjuryFeb 12, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO A DISLOCATION AND METALLOSIS.

  Patient problems: Injury

  MAUDE report 8334091 ↗
• InjuryNov 27, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO UNSPECIFIED REASONS (PAIN) TO REMOVE THE STEM AND CUP FROM THE PATIENT. NO DELAY REPORTED.

  Patient problems: Injury

  MAUDE report 8108689 ↗
• InjuryJan 8, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A SURGICAL INTERVENTION WAS PERFORMED DUE TO INSTABILITY. THE LINER AND THE HEAD WERE REMOVED.

  Patient problems: Failure of Implant

  MAUDE report 7171655 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K113848, K211176. One submission often covers many models, so check the product and lot details in each record.

• Z-0326-2025 · Oct 15, 2024 · Open, Classified
  Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femoral head bipolar component of the Tandem Bipolar Hip System.
• Z-1929-2013 · May 29, 2013 · Terminated
  R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 60 MM OD, QTY: (1), STERILE H2O2, REF 71335760. Orthopaedic.
• Z-1928-2013 · May 29, 2013 · Terminated
  R3 (TM) XLPE ACETABULAR LINER UHMWPE, 20o OVERHANG, 36 MM ID, 62 MM OD, QTY: (1), STERILE H2O2, REF 71335762. Orthopaedic.